The present invention relates to catheters and medical procedures involving catheters. More specifically, the present invention relates to wound closure devices, including vascular wound closure devices, and devices and methods for positioning wound closure devices, including relative to a blood vessel.
Various catheterization procedures require the piercing of a blood vessel, including arteries, or a body organ. Withdrawal of the catheter leaves a puncture wound that must be closed. For pierce or puncture wounds in blood vessels, traditional closure techniques involve withdrawal of the catheter and subsequent application of pressure to the area of the puncture to facilitate natural clotting. Such a technique is time consuming, and the time required and the results vary greatly from patient to patient.
The assignee of the present application owns patents and patent applications directed to vascular closure devices and their use. For example, U.S. Pat. Nos. 5,108,421, 5,192,300, 5,275,616, 5,478,352, 5,591,205, 6,601,602 and 5,716,375, all entitled “Insertion Assembly and Method of Inserting a Vessel Plug into the Body of a Patient,” disclose closure devices and methods of using them.
U.S. Pat. No. 5,306,254, which issued Apr. 26, 1994 and is incorporated herein by reference in its entirety, describes a vascular closure device and method involving introducing a mechanical seal through a sheath. Generally, the disclosed closure device enables sandwiching an arteriotomy between a bio-absorbable anchor and a collagen sponge, both of which dissolve after time. This technique consistently, reliably, and bio-mechanically seals the puncture allowing for faster recovery as well as providing for a faster completion of the procedure.
During some catheterization procedures, a catheter procedure sheath is inserted into an artery and a given medical procedure, such as, for example, a cardiac catheterization, balloon angioplasty, angiographic dye injection or the like, is performed. Upon completion, a guidewire is inserted through the catheter sheath and into the artery. The procedure sheath is then removed, leaving the guidewire in place.
The assignee's vascular closure devices may then be used to seal the puncture. More specifically, an inserter or arteriotomy locator is introduced into a sheath of the vascular closure device. The guidewire is then fed through the arteriotomy locator. The combined arteriotomy locator and sheath are then advanced into the artery through the existing puncture, guided by the guidewire.
To determine the position of the sheath during insertion, a detection orifice is provided in the arteriotomy locator, just distal to the sheath tip. The orifice is in fluid communication with a proximal orifice (or other indicator) that is visible to the surgeon. Thus, the arteriotomy locator and sheath are advanced through the artery wall, until a “flashback” (e.g., blood flow) is detected in the proximal orifice indicating that the detection orifice is within the artery. It should be understood that the present invention need not be used exclusively on arteries; however, if it is being used on an artery, the blood flow may be pulsitile. When blood flow is detected, the sheath and arteriotomy locator are then retracted just until the flashback has ceased. This indicates that the detection orifice is aligned with the interior edge of the artery wall and the sheath has been retracted from the artery. As such, the arteriotomy locator and sheath are now in a known position relative to the artery. Both can be advanced a specific distance (e.g., 1-2 cm) and the surgeon is assured of proper placement of the arteriotomy locator and sheath relative to the artery. It is desirable to limit the advancement of the sheath so as to not pass the sheath too far into the artery. Some surgeons may repeat these steps (advancing and retracting) several time to obtain a comfort level with the position of the sheath.
Once properly positioned, the arteriotomy locator and guidewire are withdrawn through the sheath. An anchor device is inserted through the sheath and into the artery. The anchor is deployed so as to engage the tip of the sheath. That is, the tip of the sheath is specifically shaped and contoured to engage the anchor and cause it to move to a locking or engaging position wherein retraction through the sheath is precluded. The sheath is withdrawn exposing a coupling to the anchor that includes a suture, an advancer, and a collagen sponge. In short, the collagen sponge in pressed against the outer artery wall by repeated strokes of the advancer. This serves to compress the collagen sponge against the outer wall while cinching the anchor to the inner wall. The suture remains and holds these components in this configuration. The exposed portion of the suture is trimmed and the anchor, suture and collagen sponge dissolve within the body after a period of time (e.g., 60-90 days). In this manner, the arteriotomy is hemostatically sealed.
The vascular closure device described above is effective at rapidly sealing an arteriotomy. However, during the initial insertion of the arteriotomy locator and sheath, the retraction of the arteriotomy locator and the sheath requires the withdrawal of the sheath from the artery. That is, the position of the detection orifice is distal to the tip of the sheath; thus, when the detection orifice is aligned with the edge of the artery wall the sheath tip is necessarily withdrawn from said wall. Upon subsequent advancement, the sheath must re-penetrate the artery wall. Such advancement occurs at least once to properly position the sheath tip within the artery and may occur several times if the surgeon elects to reposition the device. While in most instances the advancement and retraction does not cause any difficulty, repeated penetrations could potentially adversely affect the vessel wall.
Thus, there exists a need to position a vascular wound closure device relative to a blood vessel without the sheath penetrating the vessel multiple times.